Series A Asymmetrical Patella SSI000243

GUDID 00880304849525

Biomet Orthopedics, LLC

Surgical drill guide, reusable

• Primary Device ID: 00880304849525
• NIH Device Record Key: bfa28eaa-3a7e-4d68-b3a1-90c6f37eadd7
• Commercial Distribution Discontinuation: 2016-10-04
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Series A Asymmetrical Patella
• Version Model Number: SSI000243
• Catalog Number: SSI000243
• Company DUNS: 129278169
• Company Name: Biomet Orthopedics, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1(800)348-9500
• Email: customerservice@zimmerbiomet.com

Device Dimensions

• Outer Diameter: 34 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00880304849525 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K110362

FDA Product Code

• JWH: Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00880304849525]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-11-22
• Device Publish Date: 2016-10-04

On-Brand Devices [Series A Asymmetrical Patella]

• 00880304849549: SSI000245
• 00880304849532: SSI000244
• 00880304849525: SSI000243
• 00880304849518: SSI000242
• 00880304849501: SSI000241
• 00880304849495: SSI000240